Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE)

April 13, 2026 updated by: Niguarda Hospital

Ischemic And Bleeding Risk Assessment After TAVR (FOCUS ONE Registry)

Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2).

Giving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events.

Despite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of "less is more" (only SAPT or only OAC) regardless the risk level (5-6).

The keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nowadays in the post POPULAR-TAVI era, after transcatheter aortic valve replacement (TAVR), an establish uniform approach towards anticoagulation and antithrombotic therapy were established.

All patients undergoing TAVR without other indication to dual antiplatelet therapy (DAPT) or oral anticoagulation (OAC), were currently treated according with the general concept of "less is more" (only single antiplatelet therapy - SAPT or only oral anticoagulation - OAC) [1-3].

By comparing the frequency of ischemic and bleeding events, data from trial revealed that the bleeding events were more frequent than the ischemic one despite the level of surgical risk, however a gradient of reduction in terms of difference was seen from the highest to the lowest risk profile [4].

Furthermore, recent literature showed how the timeframe analysis approach, giving the possibility for a complete time variability evaluation, is able to visualize the fluctuation of the risk over the time. Unfortunately, no stratified data according with the surgical risk level, are available using this approach [5].

Moreover, despite these results that highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events, a tailored antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated with a uniform approach in terms of intensity during the time (1-3).

1.1. Assessment of ischemic and bleeding risk after TAVR according with antithrombotic therapy and surgical risk The rate of adverse thrombotic and hemorrhagic events occurred in the first days after the procedure, were mainly driven by the TAVR's access bleeding and the periprocedural stroke.

Recent study, using the average daily risk analysis, showed the prevalence of the ischemic risk in the first 30 days after the procedure followed by a rising of the bleeding one which become predominant during the follow up, affecting the long-term prognosis [5].

However, only data based on surgical risk derived from the 'first time event approach' are available in the literature and none of them investigates whether the higher expected risks - both ischemic and hemorrhagic - in the highest risk cohort remain high even months after TAVR.

Bearing this in mind, these observations revealed that ischemic and bleeding events are not evenly distributed over time, suggesting that a risk-based modulation of the antithrombotic therapy could be better capture the time-dependent evolution of the phenomena. Experience from several studies on antithrombotic therapy in the PCI field, have focused on the intensity and the timing of administration, while no such evidence exists in the field of TAVR (6-7).

Thus, the comprehension of this phenomena holds the potential benefit of a tailored antithrombotic therapy guided by an integrated approach based on the trend of ischemic and bleeding risk stratified according to the patient's risk profile and the antithrombotic regimen adopted.

1.2. Impact of prostheses type and complete blood count variables on ischemic and bleeding events As the same of patient's features and periprocedural variables, it is possible to assume that also the prostheses characteristics in terms of type of leaflet (porcine vs bovine), stent frame amount (short frame versus long frame) and the number of they (valve-in-valve), are not fully investigated previously and may play a role in the thrombotic and hemorrhagic adverse events occurrence.

Understanding the impact of structural and functional valve's characteristics on the bleeding and ischemic risk among patients who undergo TAVR, may have important implications in prosthesis and antithrombotic therapy selection and needs to be investigated properly with a "repeated-event" analysis.

Moreover, also the frequent phenomenon of anemia and thrombocytopenia after TAVR, were identified from several studies as predictors of poor outcome up to 1 year follow up even with a perfect prosthesis function and despite the mechanism behind, it's not completely understood (8). According to these data the relationship between blood count abnormalities, type of prosthesis and ischemic and bleeding risk have never been explored.

The identification of predictive variables leading to the development of anemia and thrombocytopenia and their impact on the risk of hemorrhagic and thrombotic events, might allow us a tailored selection of prosthesis, antithrombotic strategy and procedural planning in order to potentially reduce the risk of adverse events.

1.3. Dynamic therapeutic changes after TAVI Several studies investigated the impact of different antithrombotic strategies on outcomes and prosthesis performance by comparing different approaches in combination. However, most of them assessed the clinical endpoints considering only the discharge therapy, with a lack of real data in terms of regimes switching and duration of any effective treatment prescribed.

The assessment of these data during follow-up, remains underexplored even though their availability could potentially allow an accurate definition of the ongoing strategy at the time of adverse event occurrence. Moreover, the collection of these variables may provide important information about the antithrombotic management, including the reason, the rate and the timing of crossover for each treatment.

Finally, given the evolution of the antithrombotic strategy in the last years, in particular in the pre and post Popular TAVI era, and knowing the therapeutic management during the first year of follow up, it's possible to define the impact of any study/trial on the real-world approach in recent years.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Aalst, Belgium
        • Recruiting
        • OLV Hospital
  • Chile
      • Santiago, Chile
        • Recruiting
        • Complejo Asistencial Dr. Sótero del Rio
  • Czechia
      • Prague, Czechia, 10034
        • Recruiting
        • Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
  • Italy
      • Genova, Italy
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
      • Milan, Italy
        • Recruiting
        • Ospedale Galeazzi Sant'Ambrogio
      • Potenza, Italy
        • Recruiting
        • San Carlo Hospital
      • Roma, Italy
        • Recruiting
        • Azienda Ospedaliera Sant'Andrea
      • Torino, Italy
        • Recruiting
        • A.O.U. Città della Salute e Della Scienza di Torino
    • Italia
      • Milan, Italia, Italy, 20162
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Humanitas Research Hospital
      • San Donato Milanese, Milano, Italy
        • Recruiting
        • IRCCS Policlinico San Donato
  • Spain
      • Cadiz, Spain
        • Recruiting
        • Puerto Real University Hospital, Puerto Real

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with severe aortic stenosis diagnosed according to ESC guidelines, undergoing TAVR

Description

Inclusion criteria

  • All patients with severe aortic stenosis undergoing TAVR.
  • Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.

Exclusion Criteria

  • Patients who died during the index procedure
  • Patients in triple antithrombotic therapy at discharge
  • Patients with a known prognosis less than 1 year at the time of TAVR

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lower Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
Other: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

All patients undergoing TAVR will be stratified according with surgical risk level and all combination of antithrombotic therapy at discharge

Low risk (SAPT vs DAPT and OAC vs OAC+SAPT) Intermediate risk (SAPT vs DAPT and OAC vs OAC+SAPT) High risk (SAPT vs DAPT and OAC vs OAC+SAPT)
Intermediate Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
Other: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

All patients undergoing TAVR will be stratified according with surgical risk level and all combination of antithrombotic therapy at discharge

Low risk (SAPT vs DAPT and OAC vs OAC+SAPT) Intermediate risk (SAPT vs DAPT and OAC vs OAC+SAPT) High risk (SAPT vs DAPT and OAC vs OAC+SAPT)
High Surgical Risk
Surgical risk stratification. All the following groups will be define according with STS and Euroscore II score and stratified based on antithrombotic strategy in all possible combinations (SAPT, DAPT, OAC, OAC+SAPT)
Other: Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

All patients undergoing TAVR will be stratified according with surgical risk level and all combination of antithrombotic therapy at discharge

Low risk (SAPT vs DAPT and OAC vs OAC+SAPT) Intermediate risk (SAPT vs DAPT and OAC vs OAC+SAPT) High risk (SAPT vs DAPT and OAC vs OAC+SAPT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trend of average daily ischemic risk (ADIR) and average daily bleeding risk (ADBR)
Time Frame: At 30-days, 90-days and 1 year

ADIR was calculated as the total number of ischemic events (CV deaths, MI, ischemic stroke and other thrombotic events-including repeat events) divided by the number of patients-day at risk.

ADBR was calculated as the total number of bleeding events (including repeat events) divided by the number of the number of patients-day at risk.
At 30-days, 90-days and 1 year
Average daily risks (ADRs) in different type of valve prosthesis
Time Frame: At 30-days, 90-days and 1 year
Trend and prevalence of ADIR and ADBR in different type and number of prosthesis (long frame vs short frame, balloon versus self-expandable, porcine vs bovine, Single Valve vs Valve in Valve) and calculated as the total number of events divided by the number of patients-day at risk
At 30-days, 90-days and 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average daily risks (ADRs) in different type of valve prosthesis
Time Frame: At 30-days, 90-days and 1 year
Trend and prevalence of ADIR and ADBR in different type and number of prosthesis (long frame vs short frame, balloon versus self-expandable, porcine vs bovine, Single Valve vs Valve in Valve) and calculated as the total number of events divided by the number of patients-day at risk
At 30-days, 90-days and 1 year
Average daily risks (ADRs) in anaemic and thrombocytopenic patients
Time Frame: In hospital up to 1 year
Trend and prevalence of ADIR and ADBR in patients who developed anaemia and thrombocytopenia after the procedure and during the hospitalization. Anaemia and thrombocytopenia were defined according to the WHO and EHA guidelines. ADRs were calculated as the total number of events divided by the number of patients-day at risk
In hospital up to 1 year
Rate of antithrombotic regimen changes after TAVR
Time Frame: At 30-days, 90-days and 1 year
Percentage of antithrombotic strategy changes
At 30-days, 90-days and 1 year
Timing of antithrombotic regimen changes after TAVR
Time Frame: At 30-days, 90-days and 1 year
Number of days after the procedure in which the antithrombotic strategy was changed
At 30-days, 90-days and 1 year
Type of antithrombotic regimen changes after TAVR
Time Frame: At 30-days, 90-days and 1 year
Type of changes in antithrombotic strategy taking into account all interclass (antiplatelet to anticoagulant or vice versa) and intraclass drugs switches (anticoagulant - VKA to DOAC, antiplatelet - DAPT to SAPT or vice versa)
At 30-days, 90-days and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niguarda Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

November 1, 2024

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 13, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F1R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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